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Recall Observatory FDA recall evidence

Device product

Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US

Z-2437-2021

July 20, 2021

Class II

Product summary

Firm
Angiodynamics, Inc.
Event
Event 88444
Status
Terminated
Classification
Class II
Quantity
26 US, 4 OUS
Official record key
device-enforcement:Z-2437-2021

Official wording

Reason: Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up.

Code information: Serial Nos. QBY0002693 QBY0002376 QBY0002765 QBY0002380 QBY0002763 QBY0002662 QBY0002570 QBY0002683 QBY0002551 QBY0002618 QBY0002006 QBY0002293 QBY0002578 QBY0002666 QBY0002378 QBY0002375 QBY0002283 QBY0002539 QBY0002762 QBY0002681 QBY0002690 QBY0002389 QBY0002518 QBY0002670 QBY0002395 QBY0002687 QBY0002613 QBY0002664 QBY0002759 QBY0002780

Distribution pattern: Domestic distribution Nationwide. Foreign distribution worldwide.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software to help reduce the incidence of Error